Over-the-needle guidewire vascular access system

ABSTRACT

Systems and methods for accessing body tissue are disclosed. The systems and methods can include an introducer assembly for percutaneous access to a body lumen. The assembly can include a needle and an over-the-needle guidewire. The needle and the guidewire can be inserted into body tissue and the guidewire advanced into the body tissue relative to the needle. The needle can be removed after advancing the guidewire.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) as anonprovisional of U.S. Provisional Application No. 61/892,257, titledTROCAR SHEATH INTRODUCER KIT, and filed Oct. 17, 2013, the entirety ofwhich is incorporated herein by reference.

BACKGROUND

1. Field

The present application generally relates to providing access to livingbody tissue, and in particular, to medical access devices provide accessto living body tissue, including blood vessels.

2. Description of the Related Art

Many medical procedures require percutaneous placement of aninterventional medical device, such as a catheter, into a body lumensuch as an artery or vein. Such interventional medical devices may beused for, among other things, blood pressure monitoring, blood sampling,establishing access for a diagnostic and/or interventional procedure,and administering fluids and medicaments to a patient. In one aspect,percutaneous access to a patient's central venous system is an importantaspect of administering intravenous therapy. It is desirable that thetherapy be administered in the superior vena cava of the central venoussystem. In order to gain access, introducer devices are commonly used,through which other medical devices, such as a central venous catheter(CVC), are inserted. One such example of a CVC is a peripherallyinserted central catheter (PICC). A PICC typically has one or moretubes, which are externally accessible by a clinician, that convergeinto a single catheter body that is internally implanted in a vein ofthe patient. The tubes are adapted to receive medicaments, which arethen released through a distal tip of the catheter body into the centralvenous system of the patient.

In general, percutaneous techniques involve placing a needle through theskin and into a blood vessel, such as an artery or vein, until bleedbackis achieved. This is followed by introduction of a flexible introducerguidewire to define the pathway through the skin and into the passagewayor lumen of the blood vessel. The needle is then exchanged for anintroducer sheath with dilator, which are concentric tubes that areadvanced over the introducer guidewire and into the blood vessel. Theintroducer guidewire and dilator are removed, and exchanged for acatheter or other medical device to be used to deliver medication,and/or implantation of a medical implant such as a filter or a stentinto the blood vessel through the introducer sheath.

The purpose of an introducer set is to place a section of tubing, forexample an introducer sheath for a catheter, into a vessel, or otherbody part, that has a sufficiently large and rigid inner diameter tofacilitate insertion of other proportionately large tubes, catheters, orother instruments into said vessel or body part. An introducer setcommonly contains a small diameter device with a sharp tip, commonly ahypodermic needle, so that the introduction can start with a relativelysmall, easily produced, puncture wound, minimizing trauma to theinvolved tissues. This small puncture wound is then expanded, ideally bystretching rather than tearing or cutting the involved tissues, with atapered dilator. The wall thickness of the introducer sheath is in someembodiments as small as possible, minimizing the outside diameter of theintroducer sheath to minimize the trauma to the body tissues involvedwhile maximizing the size of the inside of the opening for insertion ofother devices.

Described is a procedure for preparing an opening to introduce devicesinto a blood vessel, a body opening, or other body duct is a multi-stepprocedure involving a number of independent devices and steps. Thefollowing steps set forth a conventional introducer set and method ofuse.

First, a hypodermic needle with glass or clear or translucent plasticsyringe attached, is inserted into a vessel. When the pressure in thesyringe is lower than the pressure in the vessel, blood will flow up theneedle and into the syringe where it can be observed by the operator.Observed features, such as color and rate of flow of blood, confirm thata blood vessel has been hit, and indicate the type of vessel. Theability to observe the blood is a necessary part of the procedure forblood vessel access or, for example, access to a cyst or duct.

Second, while holding the needle in place, the syringe is disconnectedfrom the needle. At this point, blood can flow, or squirt, out of theproximal opening of the needle and/or air can be sucked into the needleif the pressure in the body vessel should fall below ambient pressure.This latter effect can occur in a vein during normal inspiration, whenthe veins often collapse under negative pressure created in the venoussystem by the depression of the diaphragm.

Third, as quickly as possible, to minimize the above effects, aguidewire is inserted into the proximal end of the needle, effectivelyand approximately closing the hole and stopping fluid or air flow. Theguidewire is then threaded well into the vessel. The guidewire isflexible to turn the corner from the needle-stick track, which entersthe vessel at an acute angle.

Fourth, the needle is then removed by pulling the needle backwards overthe full length of the guidewire while simultaneously holding theguidewire in place.

Fifth, a dilator with an introducer sheath slidingly positioned over thedilator is threaded onto the proximal end of the guidewire. The distaltip of the dilator has an inner diameter just large enough to slip overthe guidewire with little friction. The outer diameter of the distal tipof the dilator is only slightly larger than the inner diameter, creatinga relatively smooth transition from guidewire to dilator. The outerdiameter of the dilator is tapered to a larger dimension, the taperoccurring over a distance of about, for example, one or more centimetersback from the tip. The distal tip of the introducer sheath is positionedjust proximal to the proximal end of the taper. As the dilator-sheathcombination is pushed forward, the tip follows the guidewire into thevessel, and the following tapered outer dimension dilates the holethrough the body and the wall of the vessel, stretching the innerdiameter of the vessel to a larger than normal diameter. The dilatormust also be flexible enough to turn the corner from the needle track tothe long axis of the vessel. However, a relatively large force may berequired to push the dilator through all the intervening tissues and toexpand the vessel diameter, so the dilator/guidewire combination shouldhave a proportionately large stiffness to prevent buckling. The distalend of the introducer sheath follows the dilator into the vessel. Thissheath commonly has a constant inner diameter, just big enough to slipover the outer diameter of the dilator, and a constant-thickness thinwall. It should be flexible enough to pass from the body tissues outsidethe vessel, enter the vessel at an angle, and turn the corner to followthe long axis of the vessel. The force required again may be relativelylarge, but the dilator prevents buckling of the thin-walled, relativelyflexible introducer sheath. Note that it could be difficult to insertthe introducer sheath over the guidewire without inserting the dilatorfirst because the required force would be great, the trauma to thetissues would be severe, and the stiffness of such a sheath would beinconsistent with the need for a flexible thin-walled device. Similarly,the size of the guidewire should be taken into consideration dependingon the size of the sheath being introduced.

Sixth, the dilator is then withdrawn, holding only the introducersheath, and perhaps the guidewire, in place. The guidewire can beremoved as well. In some cases, the guidewire can be optionallyexchanged for a second, larger diameter, stiffer guidewire, and theintroducer sheath can be removed. A larger diameter dilator can then beinserted to enlarge the percutaneous opening, and then removed. A largerdiameter introducer sheath and/or catheter (e.g., a dialysis catheter)can then be inserted. This introducer sheath permits repeated insertionand removal of useful devices of relatively large diameter, such asinfusion catheters, balloon angioplasty catheters, angioscopes, etc.into the body and through the vessel wall without repeated trauma tovessel or intervening tissues. Improved methods and devices of accessinga body lumen are needed.

SUMMARY

The necessary threading of numerous components may require a largesterile field in which to work, can be difficult to perform with justtwo hands, and often permits increased blood loss during the process.Disclosed herein are systems and methods for reducing the need formultiple threadings/percutaneous dilations, reducing the incidence ofneedle sticks in some cases (such as when the vessel is not properlycannulated, reducing the number of devices used during the procedure,reducing blood loss, reducing the time required to gain intravascularaccess, and associated healthcare costs with, for example, theforegoing. Embodiments herein disclose an assembly which can replace themultiple components, each of which must be handled separately in theclassical, conventional vascular access procedure, and reduce the numberof steps required to gain access. Additionally, embodiments hereindisclose an assembly can be used with ease by a single user, whereasconventional methods may generally require more than one person tohandle the multiple components.

Disclosed herein and in the figures and tables that follow are systemsand methods relating to an over-the-needle guidewire vascular accesssystem and components thereof, which can advantageously be deployed inless steps, and thereby provide more rapid access to, for example, abody lumen, such as an artery or vein for sample collection, infusion,or procedural access (such as a cardiovascular or vascular procedure,including angioplasty, stent placement, valve or other implantplacement, and the like). Any dimensions listed in the tables andfigures that follow are non-limiting examples, and include the listedquantitative dimensions and quantitative dimensions that areapproximately the listed dimensions.

In some embodiments, disclosed are methods of accessing a body lumen,such as a blood vessel for example, including the steps of: puncturingthe body lumen with a needle loaded with an over-the-needle wire;advancing the over-the-needle wire into the body lumen; withdrawing theneedle while maintaining the wire in position; inserting asheath/dilator having a diameter greater than that of theover-the-needle wire; and withdrawing the guidewire and dilator, leavingthe sheath inside the body lumen. In some embodiments, puncturing thebody lumen can be via a percutaneous or cut-down approach. In someembodiments, the method could include, e.g., needle, wire, sheath, anddilator features as described elsewhere herein.

In some embodiments, a vascular access system can include a needle, suchas a 24 gauge needle having one or more of a 0.022″ OD, 0.012″ or 0.014″ID, and a length of about 3.5″. The assembly can also include aguidewire having a first, e.g., proximal portion and a second, e.g.,distal portion. The distal portion of the guidewire can be sized andconfigured to be fitted over-the-needle, such as concentrically and/orcoaxially over the needle. The distal portion of the guidewire can, insome embodiments, include a lumen, such as a central lumen, configuredto house the needle therethrough, and, for example, have a 0.035″ ODand/or 0.023″ ID, and be about 2″ in length (for a 18″ total lengthguidewire). In some embodiments, the distal portion of the guidewire canhave a length that is less than about 70%, 60%, 50%, 40%, 30%, 25%, 20%,15%, 10%, or less with respect to the entire length of the guidewire, orbetween about 5-30%, about 10-20%, or about 10-15% of the entire lengthof the guidewire. The distal portion of the guidewire can, in someembodiments, be about 16″ to about 18″ in total length and/or have asolid core (no central lumen, and thus the distal portion of theguidewire may not be over-the-needle). The guidewire can be made of anyappropriate material, such as a metal, such as stainless steel ornitinol. In some embodiments, the first portion of the guidewire couldbe made of a first material, such as a polymer, while the second portionof the guidewire could be made of a second material different from thefirst material, such as a metal. In some embodiments, axially in betweenthe first portion of the guidewire and the second portion of theguidewire a needle entrance zone can be present on the guidewire thatcan be configured to allow the needle to access the central lumen of theguidewire. The needle entrance zone could include, for example, anaperture or slot/skive detail. The dilator-sheath assembly can includean introducer sheath (e.g., a 12 French sheath), and a dilator that canbe 0.035″ compatible, for example. The introducer sheath can have acentral lumen sized and configured to house the over-the-needleguidewire therethrough.

In some embodiments, a vascular access system includes one or more ofthe following: a needle having a proximal end, a sharpened distal end, atubular body, and a central lumen therethrough; an over-the-needleguidewire configured to fit over the outside diameter of the needle, theguidewire comprising a first proximal section, a second middle section,and a third distal section; the first proximal section comprises a firstcross-sectional profile in the first proximal section; the second middlesection comprises an outer tubular sidewall, a skive in the outertubular sidewall configured for passage of the needle therethrough, theguidewire having the first cross-sectional profile proximally and asecond cross-sectional profile distally, and a transition zone betweenthe first cross-sectional profile and the second cross-sectionalprofile; the second cross-sectional profile is smaller than the firstcross-sectional profile; the third distal section comprises the outertubular sidewall having the second cross-sectional profile; and/or aluer connector operably connected to the needle having at least oneinput port fluidly connected to the central lumen of the needle, and aguidewire lumen not fluidly connected to the central lumen of theneedle, the guidewire lumen configured to slidably house the guidewiretherethrough, the guidewire lumen having a longitudinal axis that formsan acute angle with respect to a longitudinal axis of the luerconnector.

In some embodiments, the vascular access system can further include oneor more of the following: the first proximal section further comprises acoil disposed at least partially over a core wire; the core wire isembedded into the guidewire in at least the third distal section; thecore wire at least partially occludes the skive; the coil of the firstproximal section comprises a wire circumferentially wound about acentral coil axis to form the coil; the wire has an outer diameter of0.006 inches; the coil formed from the wound wire has an outer diameterof about 0.035 inches; a material of the wire comprises stainless steel;a material of the core wire comprises stainless steel; the longitudinalaxis of the luer connector is parallel to a longitudinal axis of theneedle; when the guidewire slides through the guidewire lumen, theguidewire in the guidewire lumen is positioned at the acute anglerelative to the longitudinal axis of the needle; the acute angle of theguidewire is formed at the skive in the second middle section of theguidewire; the acute angle is between about 5 to 45 degrees; the acuteangle is about 15 degrees; the outer tubular wall of the second middlesection and the third distal section extends from the skive through theguidewire lumen when the guidewire is positioned over the needle; theguidewire covers a majority of an overall length of the needle when theguidewire is positioned over the needle; an outer diameter of theguidewire tapers substantially to an outer diameter of the needle at thethird distal section proximal to the sharpened distal end of the needle;an outer diameter of the needle is about 0.022 inches and an innerdiameter of the guidewire at the third distal section is about 0.024inches; the inner diameter of about 0.024 inches extends through secondmiddle section and the first proximal section; an outer diameter of theguidewire is about 0.035 inches; the first cross-sectional profile ofthe guidewire in the first proximal section is about 0.015 inches indiameter; a cross-sectional profile of the transition zone of theguidewire between the first cross-sectional profile and the secondcross-sectional profile is about 0.010 inches in a dimension of thecross-sectional profile of the transition zone; the cross-sectionalprofile of the transition zone is round and the dimension of thetransition zone is a diameter; a first dimension of the secondcross-sectional profile is less than about 0.015 inches; a seconddimension of the second cross-sectional profile is about 0.004 inchessuch that the second cross-sectional profile is substantiallyrectangular; the skive has an opening length of about 0.060 inches whenthe needle passes therethrough; the skive has an overall length in theguidewire of about 0.080 inches when the needle passes therethrough; anentirety of a perimeter of the skive formed in guidewire is above aplane passing through a central longitudinal axis of the guidewire; amaterial of the guidewire comprises a polymer; a material of the secondmiddle section and the third distal section comprises a polymer; theguidewire has an entire length of about 45 centimeters; and/or acombined length of the second middle section and the third distalsection is less than about 30% of an entire length of the guidewire.

In some embodiments, a vascular access system includes one or more ofthe following: a needle having a proximal end, a sharpened distal end, atubular body, and a central lumen therethrough; an over-the-needleguidewire configured to fit over the outside diameter of the needle, theguidewire comprising a proximal section and a distal section; theproximal section comprises a first cross-sectional profile in theproximal section; the distal section comprises an outer tubularsidewall, a skive in the outer tubular sidewall configured for passageof the needle therethrough, the guidewire having the firstcross-sectional profile proximally and a second cross-sectional profiledistally, and a transition zone between the first cross-sectionalprofile and the second cross-sectional profile; the secondcross-sectional profile is smaller than the first cross-sectionalprofile; and/or a luer connector operably connected to the needle havingat least one input port fluidly connected to the central lumen of theneedle, and a guidewire lumen not fluidly connected to the central lumenof the needle, the guidewire lumen configured to slidably house theguidewire therethrough, the guidewire lumen having a longitudinal axisthat forms an acute angle with respect to a longitudinal axis of theluer connector.

In some embodiments, a luer for use with a needle for accessing a bodylumen includes one or more of the following: an adapter configured toaccept to a needle for penetrating body tissue to provide access to abody lumen; a fluid channel connected to the adapter, the fluid channelconfigured to fluidly connect to a central lumen of the needle when theneedle is in the adapter; a guidewire opening configured to accept aguidewire therethrough, the guidewire configured to be positioned overthe needle; the guidewire opening is not in fluid communication with thelumen of the needle; and/or the guidewire opening is configured toposition a proximal portion of the guidewire that passes through theguidewire opening at a predetermined angle relative to a distal portionof the guidewire that is positioned over the needle.

In some embodiments, the luer can further include one or more of thefollowing: a longitudinal axis of the fluid channel and a longitudinalaxis of the guidewire opening are at the predetermined angle relative toeach other; the predetermined angle is between about 5 to 45 degrees;the predetermined angle is about 15 degrees; a hub in fluidcommunication with the fluid channel, the hub configured to connect toan adapter of a syringe; a longitudinal axis of the hub is parallel alongitudinal axis of the hub; and/or gripping panels on the luer for auser to grip the luer while using the luer; a material of the luercomprises a transparent polymer.

In some embodiments, a luer for use with a needle for accessing a bodylumen includes one or more of the following: an adapter configured toaccept to a needle for penetrating body tissue to provide access to abody lumen; a fluid channel connected to the adapter, the fluid channelconfigured to fluidly connect to a central lumen of the needle when theneedle is in the adapter; a guidewire opening configured to accept aguidewire therethrough, the guidewire configured to be positioned overthe needle; the guidewire opening is not in fluid communication with thelumen of the needle; the guidewire opening is configured to position aproximal portion of the guidewire that passes through the guidewireopening at a predetermined angle relative to a distal portion of theguidewire that is positioned over the needle; and/or the guidewireopening is sized for the guidewire to slide therethrough while thepredetermined angle is maintained between a sliding portion of theguidewire in the guidewire opening and at least a part of the distalportion of the guidewire that is over the needle.

In some embodiments, the luer can further include one or more of thefollowing: a longitudinal axis of the fluid channel and a longitudinalaxis of the guidewire opening are at the predetermined angle relative toeach other; the predetermined angle is between about 5 to 45 degrees;the predetermined angle is about 15 degrees; a hub in fluidcommunication with the fluid channel, the hub configured to connect toan adapter of a syringe; a longitudinal axis of the hub is parallel alongitudinal axis of the hub; and/or gripping panels on the luer for auser to grip the luer while using the luer; a material of the luercomprises a transparent polymer.

In some embodiments, a luer for use with a needle for accessing a bodylumen includes one or more of the following: an adapter configured toaccept to a needle for penetrating body tissue to provide access to abody lumen; a fluid channel connected to the adapter, the fluid channelconfigured to fluidly connect to a central lumen of the needle when theneedle is in the adapter; a guidewire opening configured to slidinglyaccept a guidewire therethrough, the guidewire configured to bepositioned over the needle; and/or the guidewire opening is configuredto position a proximal portion of the guidewire that passes through theguidewire opening at a predetermined angle relative to a distal portionof the guidewire that is positioned over the needle.

In some embodiments, the luer can further include one or more of thefollowing: a longitudinal axis of the fluid channel and a longitudinalaxis of the guidewire opening are at the predetermined angle relative toeach other; the predetermined angle is between about 5 to 45 degrees;the predetermined angle is about 15 degrees; a hub in fluidcommunication with the fluid channel, the hub configured to connect toan adapter of a syringe; a longitudinal axis of the hub is parallel alongitudinal axis of the hub; and/or gripping panels on the luer for auser to grip the luer while using the luer; a material of the luercomprises a transparent polymer.

In some embodiments, a guidewire for use with a needle for accessing abody lumen includes one or more of the following: a first portioncomprising a coil and a core wire, the core wire housed within the coil;a second portion distal to the first portion along the guidewire, thesecond portion comprising the core wire and a tube adjacent to the coil,the tube forming a tube lumen, the core wire housed within the tubelumen, the tube comprising an opening communicating with the tube lumen,the opening positioned in the second portion; the opening is configuredto accept a needle therethrough and into the tube lumen; and/or a thirdportion distal to the second portion along the guidewire, the secondportion between the first portion and the third portion, the thirdportion comprising the core wire and the tube having the tube lumen, thecore wire housed within the tube lumen along the third portion andconfigured to extend adjacent the needle when the needle is insertedinto the tube lumen in the third portion.

In some embodiments, the guidewire can further include one or more ofthe following: the coil comprises a cord that is circumferentiallycoiled about a central axis shared by the core wire and the coil, thecord that is coiled forming a cord lumen to house the core wireconcentrically with the coil; a cross-sectional profile of the core wirebecomes smaller in at least one dimension as the core wire extends fromthe second portion to the third portion; the cross-sectional profile ofthe core wire is round as the core wire extends from the first portionto the second portion; the cross-sectional profile tapers from about0.015 inches in diameter to about 0.010 inches in diameter as the corewire extends from the second portion to the third portion; thecross-sectional profile of the core wire tapers to be rectangular in thethird portion; the rectangular cross-sectional profile has dimensions ofabout 0.010 inches by 0.004 inches; an inner diameter of the thirdportion is about 0.024 inches; the inner diameter of about 0.024 inchesextends through second portion and the first portion; an outer diameterof the first, second, and third portions is about 0.035 inches; the corewire in the first portion has a diameter of about 0.015 inches; the corewire is embedded into the guidewire in at least the third portion; thecore wire at least partially occludes the opening; the opening has anopening length of about 0.060 inches when the needle is acceptedtherethrough; the opening has an overall length in the guidewire ofabout 0.080 inches when the needle is accepted therethrough; an entiretyof a perimeter of the opening formed in the guidewire is above a planepassing through a central longitudinal axis of the guidewire; the firstportion of the guidewire is configured to intersect the needle at anacute angle when the needle is accepted therethrough; the coil of thefirst portion comprises a wire circumferentially wound about a centralaxis to form the coil; the wire has an outer diameter of 0.006 inches;the coil formed from the wound wire has an outer diameter of about 0.035inches; a material of the wire comprises stainless steel; a material ofthe guidewire comprises a polymer; a material of the second portion andthe third portion comprises a polymer; a material of the core wirecomprises stainless steel; the guidewire has an entire length of about18 inches or 45 centimeters; and/or a combined length of the secondportion and the third portion is less than about 30% of an entire lengthof the guidewire.

In some embodiments, a guidewire for use with a needle for accessing abody lumen includes one or more of the following: a first portioncomprising a coil and a core wire, the core wire housed within the coil;a second portion distal to the first portion along the guidewire, thesecond portion comprising the core wire and a tube adjacent to the coil,the tube forming a tube lumen, the core wire housed within the tubelumen, the tube comprising an opening communicating with the tube lumen,the opening positioned in the second portion; the opening is configuredto accept a needle therethrough and into the tube lumen; and/or a thirdportion distal to the second portion along the guidewire, the secondportion between the first portion and the third portion, the thirdportion comprising the core wire and the tube having the tube lumen, thecore wire housed within the tube lumen along the third portion andtapers in cross-sectional profile to abut the needle when the needle isinserted into the tube lumen in the third portion to retain asubstantially same diameter of the tube lumen from the second portion tothe third portion.

In some embodiments, the guidewire can further include one or more ofthe following: the coil comprises a cord that is circumferentiallycoiled about a central axis shared by the core wire and the coil, thecord that is coiled forming a cord lumen to house the core wireconcentrically with the coil; a cross-sectional profile of the core wirebecomes smaller in at least one dimension as the core wire extends fromthe second portion to the third portion; the cross-sectional profile ofthe core wire is round as the core wire extends from the first portionto the second portion; the cross-sectional profile tapers from about0.015 inches in diameter to about 0.010 inches in diameter as the corewire extends from the second portion to the third portion; thecross-sectional profile of the core wire tapers to be rectangular in thethird portion; the rectangular cross-sectional profile has dimensions ofabout 0.010 inches by 0.004 inches; an inner diameter of the thirdportion is about 0.024 inches; the inner diameter of about 0.024 inchesextends through second portion and the first portion; an outer diameterof the first, second, and third portions is about 0.035 inches; the corewire in the first portion has a diameter of about 0.015 inches; the corewire is embedded into the guidewire in at least the third portion; thecore wire at least partially occludes the opening; the opening has anopening length of about 0.060 inches when the needle is acceptedtherethrough; the opening has an overall length in the guidewire ofabout 0.080 inches when the needle is accepted therethrough; an entiretyof a perimeter of the opening formed in the guidewire is above a planepassing through a central longitudinal axis of the guidewire; the firstportion of the guidewire is configured to intersect the needle at anacute angle when the needle is accepted therethrough; the coil of thefirst portion comprises a wire circumferentially wound about a centralaxis to form the coil; the wire has an outer diameter of 0.006 inches;the coil formed from the wound wire has an outer diameter of about 0.035inches; a material of the wire comprises stainless steel; a material ofthe guidewire comprises a polymer; a material of the second portion andthe third portion comprises a polymer; a material of the core wirecomprises stainless steel; the guidewire has an entire length of about18 inches or 45 centimeters; and/or a combined length of the secondportion and the third portion is less than about 30% of an entire lengthof the guidewire.

In some embodiments, a guidewire for use with a needle for accessing abody lumen includes one or more of the following: a first portioncomprising a coil and a core wire, the core wire housed within the coil;and/or a second portion distal to the first portion along the guidewire,the second portion comprising the core wire and a tube adjacent to thecoil, the tube forming a tube lumen, the core wire housed within thetube lumen, the tube configured to accept a needle therethrough and intothe tube lumen with the core wire extending adjacent the needle in thesecond portion when the needle is inserted into the tube lumen of thesecond portion.

In some embodiments, a method for accessing a blood vessel with anover-the-needle guidewire includes one or more of the following:puncturing the blood vessel with a needle having an over-the-needleportion of a guidewire disposed on the needle; advancing theover-the-needle portion of the guidewire into the blood vessel whilemaintaining a position of the needle relative to the blood vessel; theguidewire comprises a proximal portion, the over-the-needle portion, anda support wire; the support wire is housed within a lumen in guidewire,the lumen extending through the proximal portion and the over-the-needleportion of the guidewire; the support wire extends from the proximalportion at least partially into the over-the-needle portion adjacent tothe needle within the lumen of the guidewire when the needle ispuncturing the blood vessel, the support wire configured to directadvancing forces on the guidewire along the needle while theover-the-needle portion of the guidewire is being advanced into theblood vessel; and/or the needle from the over-the-needle portion of theguidewire while maintaining a position of the advanced guidewirerelative to the blood vessel.

In some embodiments, the method for accessing a blood vessel can furtherinclude one or more of the following: the guidewire is pushed at anabout 15 degree angle relative to a longitudinal axis of the needle whenthe guidewire is being advanced into the blood vessel; advancing adilator and a sheath over the guidewire into the blood vessel;withdrawing the guidewire and the dilator while maintaining a positionof the sheath within the blood vessel; and/or before puncturing theblood vessel with the needle, further including one or more of thefollowing: advancing the guidewire through a guidewire port of a luer;the luer is connected to the needle to position the needle as desiredrelative to the blood vessel; the guidewire port is angled relative to alongitudinal axis of the needle, the guidewire port positioning theproximal portion of the guidewire at a predetermined angle relative tothe longitudinal axis of the needle; inserting the needle into anopening in the guidewire, the opening positioned on a middle portion ofguidewire, the middle portion between the proximal portion and theover-the-needle portion of the guidewire, the opening in communicationwith the lumen of the guidewire; advancing the needle adjacent thesupport wire into the lumen of the over-the-needle portion of theguidewire; and/or while the over-the-needle portion of the guidewire isbeing advanced into the blood vessel, the proximal portion of theguidewire advances through the guidewire port and is maintained at thepredetermined angle relative to the longitudinal axis of the needle.

The foregoing is a summary and contains simplifications, generalization,and omissions of detail. Those skilled in the art will appreciate thatthe summary is illustrative only and is not intended to be in any waylimiting. Other aspects, features, and advantages of the devices and/orprocesses and/or other subject matter described herein will becomeapparent in the teachings set forth herein. The summary is provided tointroduce a selection of concepts in a simplified form that are furtherdescribed below in the Detailed Description. This summary is notintended to identify key features or essential features of any subjectmatter described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly some embodiments in accordance with the disclosure and are,therefore, not to be considered limiting of its scope, the disclosurewill be described with additional specificity and detail through use ofthe accompanying drawings.

FIG. 1 illustrates a side, top, perspective view of an exampleembodiment of a vascular access system.

FIG. 2 illustrates a side view of an example embodiment of a vascularaccess system.

FIG. 3 illustrates a side, top, perspective view of an exampleembodiment of a luer.

FIG. 4 illustrates a side, top, perspective view of a cross-section ofan example embodiment of a luer.

FIG. 5 illustrates a side, bottom, perspective view of an exampleembodiment of a vascular access system.

FIG. 6 is a cross-sectional profile view of an example embodiment of atip, a needle, and a ribbon.

FIG. 7 illustrates a side view of an example embodiment of a needle anda guidewire over the needle.

FIG. 8 illustrates a side view of an example embodiment of a guidewire.

FIG. 9A illustrates an enlarged side view of an example embodiment of aguidewire.

FIG. 9B illustrates an enlarged side of a cross-section of an exampleembodiment of a guidewire.

FIGS. 10A-C illustrate an example method of using a vascular accesssystem as discussed herein.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description and drawings are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presented here.It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in thefigures, may be arranged, substituted, combined, and designed in a widevariety of different configurations, all of which are explicitlycontemplated and made a part of this disclosure.

In particular, embodiments disclosed herein pertain to access devices orintroducer sets used to obtain access (e.g., percutaneous) to a livingbody tissue (e.g., a body lumen, including canalization of bloodvessels) to facilitate the passage of catheters through tissue andvascular walls while reducing the number of components threaded over aguidewire.

FIG. 1 illustrates a side, top, perspective view of an exampleembodiment of a vascular access system 2. The vascular access system 2can have a needle 4 (e.g., a cannula). The needle 4 can have a sharpeneddistal end 6 (e.g., a beveled end) to allow for percutaneous access ofbody tissue. The needle 4 can have a central lumen 8.

The needle 4 can be, for example, a 24 gauge needle. In someembodiments, the needle 4 can have a 0.022″ (inch) outer diameter (OD),0.012 to 0.014″ (inch) inner diameter, and a length of about 3.5″(inches). In some embodiments, the needle 4 can have any otherappropriate gauge, including 19 gauge (0.042″ OD, 0.027″ ID), 20 gauge(0.036″ OD, 0.023″ ID), 21 gauge (0.032″ OD, 0.020″ ID), 22 gauge(0.028″ OD, 0.016″ ID), 22s gauge (0.028″ OD, 0.006″ ID), 23 gauge(0.025″ OD, 0.013″ ID), gauge 25 (0.020″ OD, 0.010″ ID), 26 gauge(0.018″ OD, 0.010″ ID), 26s gauge (0.018″ OD, 0.006″ ID), 27 gauge(0.016″ OD, 0.008″ ID), and 28 gauge (0.014″ OD, 0.007″ ID), includingsmaller or larger gauge needles and the corresponding outer and innerdiameters, and any ranges involving any of the aforementioneddimensions, including from a 24 gauge to a 18 gauge needle, or from a 24gauge to a 20 gauge needle for example, and overlapping ranges thereof.In some embodiments, the length of the needle 4 can appropriatelycorrespond to a length of the third distal section of the guidewire 16as discussed herein. The length of the needle 4 (e.g., an entire length)can be less than about 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4,3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, or 4.5 inches, and morethan 4.5 inches, including the foregoing values and ranges borderingtherein, such as between about 2.5 inches and about 4.5 inches, orbetween about 3 inches and about 4 inches for example. The needle 4 canbe made of, for example, stainless steel, nitinol (nickel titanium),and/or other suitable metals or metal alloys. The composition of theneedle 4 composition can provide echogenicity (e.g., the ability tobounce an echo, such as return a signal in ultrasound examinations).

The vascular access system 2 can have a luer 10. The needle 4 of thevascular access system 2 can have a proximate needle end 12. Theproximate needle end 12 can be connected to the luer 10. The centrallumen 8 of the needle 4 can be fluidly connected to an input port 36 ofthe luer 10 as discussed here in, and in particular, as discussed inreference to FIG. 4. The luer 10 can be made of, for example, a polymer.The luer 10 can polycarbonate. The luer 10 can be substantially clear ortransparent to allow for viewing the guidewire lumen 20 and port 36.Having a viewable guidewire lumen 20 can facilitate observing whetherthe guidewire 16 is properly translating through the guidewire lumen 20as discussed herein. Having a viewable port 36 can facilitate viewingbleedback or a flash during insertion the needle 4 into body tissue. Insome embodiments, the luer 10 can be made of polymers including, forexample, polyethylene terephthalate (PET), metalized PET, low-densitypolyethylene, high-density polyethylene, nylon, polyolefin, blends ofpolyolefin, polystyrene, blends of polyolefin and polystyrene,polyester, blends of polyester, etc.

The luer 10 can have a needle adapter 14. The needle 4 can be connectedto the luer 10 via the needle adapter 14. The needle adapter 14 can besized and shaped to correspond to and securely engage the needle 4 inposition relative to the luer 10. The needle adapter 14 can have anadapter port 15 that engages, mates, and/or connects to the needle 4 tosecure the needle relative to the luer 10. The needle adapter 14 can bemade from the same or different materials as the luer 10 as discussedherein. The needle adapter 14 can be substantially clear or transparentas discussed herein for the luer 10.

The vascular access system 2 can have a guidewire 16. The guidewire 16can have a skive 18 (e.g., an opening, aperture, or slot formed in theguidewire 16) that provides an opening for a passageway through theguidewire 16 as discussed herein (e.g., the skive 18 communicates withand provides access to a lumen of the guidewire 16). The needle 4 forcan be inserted into the skive 18 and the guidewire 16 to slide over theneedle 4. The guidewire 16 can be sized and shaped to correspond to theouter diameter of the needle 4. For example, the inner diameter of theguidewire 16 can correspond to or be about the same size as the outerdiameter of the needle 4 as discussed herein. The inner diameter of theguidewire 16 can be sized to provide a secure fit over the needle 4without the guidewire 16 freely sliding off of the needle 4 (e.g.,without the application of an external force). Concomitantly, the innerdiameter of the guidewire 16 can be sized to provide sufficientclearance relative to the outer diameter of the needle 4 for theguidewire 16 to slide off the needle 4 when desired (e.g., when a userapplies an external force to the guidewire 16 and pulls out the needle4). The inner diameter of the guidewire 16 can be sized to accommodatethe core wire 42 (e.g., the ribbon 44) while the needle 4 is in theguidewire 16 as discussed herein.

As illustrated in FIG. 1, the luer 10 can have a guidewire lumen 20. Insome embodiments, the guidewire lumen 20 is not fluidly connected to theadapter port 15 and/or port 36 of the luer 10. The guidewire lumen 20can be configured to slidably accept and/or engage the guidewire 16. Theguidewire lumen 20 can be sized and shaped such that the guidewire 16can slide (e.g., relatively freely slide or with minimal impedance),within the guidewire lumen 20 as discussed herein, and can alsoadvantageously assist in guiding the guidewire 16 as it moves over theneedle 4, and reduce the possibility of fraying or other damage to theguidewire 16, such as proximate the skive 18. The guidewire lumen 20 canbe oriented within the luer 10 to direct, position, and/or hold theguidewire at a predetermined angle relative to the needle 4 and/or luer10 as discussed herein, and in particular, as discussed in reference toFIGS. 2 and 4. In FIG. 1, the proximal guidewire 16 and associatedguidewire lumen 20 is shown as generally inferior to the luer. However,in some embodiments, the proximal guidewire 16 and associated guidewirelumen 20 can be positioned generally superior to the luer 10, orlaterally in other embodiments.

FIG. 2 illustrates a side view of an example embodiment of a vascularaccess system 2. As illustrated in FIG. 2, the guidewire 16 can passthrough a central body of the luer 10. For example, the guidewire 16 canpass through the guidewire lumen 20 as discussed herein. The guidewirelumen 20 can direct and/or position the guidewire 16 at a predeterminedguidewire angle θ 22. In some embodiments, the guidewire angle 22 can beabout 15 degrees. In some embodiment, the guidewire angle 22 can rangebetween about 5 to 45 degrees, including about 5 to 35, 5 to 30, 5 to25, 5 to 20, 5 to 15, 5 to 10, 10 to 35, 10 to 30, 10 to 30, 10 to 25,10 to 20, 10 to 15 degrees, including the foregoing values and rangesbordering therein. The guidewire angle 22 can be considered relative tothe longitudinal axis of the needle 4 (e.g., central lumen 8 of theneedle and/or a longitudinal axis of the port 36, see FIG. 4).

The guidewire angle 22 can be varied depending on the guidewire lumen 20directing the pushability of the guidewire 16 (e.g., due to the corewire 42 as discussed herein) along the needle 4 as desired. Accordingly,the guidewire angle 22 can vary based on the design of the guidewire 16.As discussed herein, the guidewire 16 may vary in stiffness to enhancethe pushability or ability of the vascular access system 2 to push theguidewire 16 through and into the living tissue (e.g., vasculature). Thestiffer the guidewire 16, the smaller guidewire angle 22 may be, in somecases. A balance may be achieved between a stiffness and/or rigidity ofthe guidewire 16 and the guidewire angle 22 imparted on the guidewire 16by the luer 10 for a desired pushability or ability of the vascularaccess system 2 to push the guidewire 16 through and into the livingtissue (e.g., vasculature). The guidewire angle 22 may also varydepending the comfort or ability to push the guidewire 16 along theneedle 4.

In some embodiment, the stiffness and/or rigidity of the guidewire 16and/or the guide angle 22 may vary depending on procedure to beperformed. For example, if the body tissue to be accessed is an awkwardor difficult position to reach, a varying stiffness guidewire 16 and/orguidewire angle 22 may be chosen for the desired procedure. As anotherexample, if the body tissue is “thick” at a desired location,corresponding stiffness guidewire 16 and/or guidewire angle 22 may bechosen. Varying stiffness of guidewires 16 and/or luers 10 with varyingguidewire angles 22 may be provided in a kit and chosen by a userdepending on desired pushability and/or body tissue site as discussedherein. In some embodiments, the guidewire 16 has a first stiffnessproximally and a second stiffness distally, the first stiffness beinggreater than the second stiffness. In some embodiments, the guidewirehas a Shore durometer in a proximal portion that is about or at leastabout 10%, 20%, 30%, 40%, 50%, 75%, 100%, 150%, 200%, or more greaterthan a durometer in a distal portion of the guidewire.

FIG. 3 illustrates a side, top, perspective view of an exampleembodiment of a luer 10. The luer 10 can have a hub 26. The hub 26 canbe shaped and sized to engage, mate with, and/or connect to any standardadapter of, for example, a syringe. The hub 26 can mate with othersuitable medical device. The hub 26 can have a lock fitting 28. The lockfitting 28 can securely engage a hub of a syringe or securely engage anyother suitable medical device. The lock fitting 28 can be threaded tomate with other threaded connections. The hub 26 and/or lock fitting 28can be made from the same or different materials as the luer 10 asdiscussed herein. The hub 26 and/or lock fitting 28 can be substantiallyclear or transparent as discussed herein for the luer 10.

The luer 10 can have gripping panels 24. The gripping panels 24 can besized and shaped to facilitate a user holding (e.g., gripping withfingers) and guiding the vascular access system 2 for percutaneousaccess of body tissue as discussed herein. As illustrated, the grippingpanel 24 can include rounded panels on the luer 10 that provide channelsand/or grooves for a user to comfortably grip the luer 10.

FIG. 4 illustrates a side, top, perspective view of a cross-section ofan example embodiment of a luer 10. As discussed herein, the needleadapter 14 can be sized and shaped to correspond to and engage, matewith, and/or connect to the needle 4 in position relative to the luer12. The needle adapter 14 can have an adapter lumen 30 that securelyengages the needle 4. A section of the adapter lumen 30 (e.g., proximalsection) can have an inner diameter that corresponds to an innerdiameter of a central lumen 8 of the needle 4. A section of the adapterlumen 30 (e.g., distal section) have an inner diameter that correspondsto an outer diameter of the needle 4. The inner diameter of, forexample, the distal section of the adapter lumen 30 can be sized andshaped to securely engage the needle 4 as discussed herein.

The luer 10 can have a luer lumen 32. The luer lumen 32 can be fluidlyconnected to the adapter lumen 30. The luer lumen 32 can fluidly connectto a hub lumen 34. The hub lumen 34 can be sized and shaped tocorrespond to and engage, mate with, and/or connect to a medical devicesuch as, for example, a syringe. An adapter of a syringe can be insertedinto the hub lumen 34. The diameter of the luer lumen 32 can correspondto an inner diameter of, for example, a syringe adapter to facilitatefluid flow between the needle 4, luer 10, and/or for example, a syringe.The combination of or anyone of the adapter lumen 30, luer lumen 32,and/or hub lumen 34 can be considered a port 36 of the luer 10 fluidlyconnecting a medical device (e.g., a syringe) connected to the luer 10via the hub 26 to the needle 4 connected to the luer 10 via the adapter14. The combination of or anyone of the adapter lumen 30, luer lumen 32,and/or hub lumen 34 can be axially aligned along a longitudinal axis 39to form the port 36 of the luer 10.

As illustrated in FIG. 4, the guidewire lumen 20 and the port 36 can beindependent of each other and the luer 10. Stated differently, theguidewire lumen 20, in some embodiments, is not in fluid communicationwith the port 36 of the luer 10 and/or the central lumen 8 of the needle4. The guidewire lumen 20 can extend along a longitudinal axis 41 (e.g.,along a straight line). The configuration of the guidewire lumen 20 notbeing in fluid communication with the port 32 can allow for the desiredpositioning of the guidewire 16 (e.g. providing a desired/predeterminedguidewire angle 22) while still allowing for the functionality of thevascular access system 2 to provide indication of bleedback or flashduring insertion of the needle 4 and guidewire 16 in body tissue asdiscussed herein.

As illustrated in FIG. 4, the guidewire lumen 20 can be substantiallystraight through a body of the luer 10 (e.g., along the longitudinalaxis 41). The guidewire loom and 20 can be straight to provide a smoothtravel path to the guidewire 16 as discussed herein. For example, theguidewire 16 can smoothly transition or slide within the guidewire lumen20 with minimal impedance or obstruction. The axial orientation of theguidewire lumen 20 relative to the axial orientation of the port 36(e.g., orientation of the longitudinal axis 39 and the longitudinal axis41) can impart the guidewire angle 22 on the guidewire 16 when theguidewire 16 is disposed over the needle 4 as discussed herein. Forexample, a substantially straight guidewire lumen 20 can be oriented atthe angle guidewire 22 relative to the port 36 that is axially alignedwith the needle 4 to impart the guidewire angle 22 to the guidewire 16at the skive 18 relative central lumen 8 of the needle 4 and/or acentral axis of the guidewire over the needle 4. In reference to FIG. 4,the central axis of the guidewire 16 can coincide with the central axisof the guidewire 16 portion over the needle 4.

FIG. 5 illustrates a side, bottom, perspective view of an exampleembodiment of a vascular access system 2. A portion of the guidewire 16is shown transparently for illustration purposes. In particular, a tip(e.g., tube) 38 of the guidewire 16 is shown transparently to illustrateother components of the guidewire 16 as discussed herein. The tip 38 ofthe guidewire 16 can have an inner diameter (e.g., lumen of the tip38/guidewire 16) that corresponds to an outer diameter of the needle 4as discussed herein. The inner diameter can be shaped to accommodate theouter diameter of the needle 4 as discussed herein to provide a securefit (e.g., not slide freely slide off the needle 4), but provideclearance sufficient to slide the tip 38 from the needle 4 when desired.For example, the tip 38 can correspond to a 21 gauge ID and OD when aneedle 4 corresponds to 24 gauge ID and OD. In an example embodiment,the needle 4 can have about a 0.022″ OD while the tip 38 can have abouta 0.024″ ID. A relatively larger inner diameter of the guidewire 16relative to the outer diameter of the needle 4 can be sized toaccommodate the ribbon 44 as discussed herein.

A distal section 40 of the tip 38 can be tapered. The distal section 40of the tip 38 can taper at or near the distal end 6 of the needle 4 tosubstantially the OD of the needle 4. The tapered distal section 40 canprovide smooth stretching (rather than tearing) of the body tissue asthe needle 4 is advanced through the body tissue (e.g., an atraumatictip).

In some embodiments, the tip 38 of the guidewire 16 can be made ofpolymer such as integrally thermoformed plastic. In some embodiments,the tip 38 can be made from polymers such as fluorinated ethylenepropylene (FEP) and/or polytetrafluoroethylene (PTFE). In someembodiments, the tip 38 can be made of polymers such as polyethyleneterephthalate (PET), metalized PET, low-density polyethylene,high-density polyethylene, nylon, polyolefin, blends of polyolefin,polystyrene, blends of polyolefin and polystyrene, polyester, blends ofpolyester, etc. The tip 38 of the guidewire 16 can be made of anysuitable material, including the aforementioned material, to provide aflexible tip 38 of the guidewire 16 that is able to engage (slide over)needle 4 and bend to a desired guidewire angle 22 as discussed herein.The tip 38 can include radiopaque fillers that can increase the opacityof guidewire 16 to, for example, make the guidewire 16 visible underfluoroscopy and/or x-rays without or minimally sacrificing themechanical properties of the polymer(s) of the guidewire 16 as discussedherein. The composition of the tip 38 can provide echogenicity (e.g.,the ability to bounce an echo, such as return a signal in ultrasoundexaminations). The composition and features of the tip 38 as discussedherein can provide a guidewire 16 that is atraumatic (e.g., causingminimal tissue injury upon insertion into body tissue).

The guidewire 16 can have a core wire (e.g., support wire or pushingwire) 42 that runs concentric with the guidewire 16 through a portion ofthe tip 38. The core wire 42 can be sized and shaped to fit within thetip 38 of the guidewire 16. For example, in certain sections of theguidewire 16, the core wire 42 can have an outer diameter thatcorresponds to the inner diameter of the tip 38 of the guidewire 16. Theouter diameter of the core wire 42 can be a similar diameter as theouter diameter of the needle 4. In some embodiments, the outer diameterof the core wire 42 may relatively larger than the outer diameter of theneedle 4 such that the core wire 42 securely engages the guidewire 16,tip 38, and/or other sections of the guidewire 16. For example, theouter diameter of the tip 38 can be sized to prevent or inhibit movementof the core wire 42 within the tip 38 and/or other section of theguidewire 16. As illustrated in FIG. 5, an assembly of the tip 38 andcore wire 42 can extend into the guidewire lumen 20 to pass through theluer 10 as discussed herein.

The core wire 42 can be made of any suitable rigid or stiff material toachieve pushability of the guidewire 16 as discussed herein. In someembodiments, the material of the core wire 42 can be stainless steel,nitinol (nickel titanium), and/or other suitable metals or metal alloys.In some embodiments, the core wire 42 can be of any suitable rigid orstiff polymer as discussed herein for the tip 38, but with increasedrigidity or stiffness relative to the tip 38 that can be achieved viaeither the process in forming the core wire 42 and/or types or blends ofmaterials used.

As illustrated in FIG. 5, the core wire 42 can gradually reduce indiameter and/or size in the guidewire 16 leading to the skive 18. Thecore wire 42 can gradually and/or smoothly taper from the outer diameterof the core wire 42 as discussed herein to a ribbon 44. The tapering ofthe core wire 42 can begin, for example, at or near the guidewire lumen20 in the luer 10. As illustrated in FIG. 5, the tapering of the corewire 42 can begin more proximate to the needle 4 relative to theguidewire lumen 20. For example, in an embodiment, proximal to theguidewire lumen 20, the core wire 42 can be about 0.015″ in diameter(e.g., outer diameter). As the core wire 42 approaches the skive 18, thecore wire 42 can taper to about 0.010″ in diameter (e.g., while stillremaining substantially circular or round). In some embodiments, thecore wire 42 can taper from a first larger diameter to a second smallerdiameter that is about, no more than about, or at least about 10%, 15%,20%, 25%, 30%, 35%, 40%, 45%, 50% less than the first diameter, orbetween about 25% and about 40% less than the first diameter.

As the core wire 42 extends near the skive 18 and past the skive 18, thecore wire 42 can taper down to the ribbon 44, which can be about0.004″×0.010″ at the distal end of the ribbon 44 (e.g., approaching thedistal end 6 of the needle 4). In reference to the orientation of theribbon 44 as illustrated in FIG. 6, the ribbon can be about 0.004″ inheight and about 0.010″ in width. In some embodiment, a first dimensionor the height (in reference to FIG. 6) of the ribbon 44 may be about0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, or0.010″, including the foregoing values and ranges bordering therein,such as between about 0.001″ and about 0.010″, or between about 0.002″and about 0.006″ for example. In some embodiment, a second dimension orthe width (in reference to FIG. 6) of the ribbon 44 may be about 0.005,0.006, 0.007, 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, 0.015,0.016, 0.017, 0.018, 0.019 and 0.020″, including the foregoing valuesand ranges bordering therein, such as between about 0.005″ and about0.020″, or between about 0.007″ and about 0.015″ for example. Thedimensions discussed herein in reference to the core wire 42 and/orribbon 44 can vary to correspond to the possible variation in dimensionsof the needle 4, gauge wire 16, tip 38, and/or coil wire 52 (see FIG. 8)as discussed herein, and in particular as discussed herein in referenceto the variation in dimension of the diameters of the needle 4.

The core wire 42 can taper to a ribbon 44 that can at least partiallyocclude the skive 18. In some embodiments, the core wire 42 and/orribbon 16 can occlude a majority or all of the skive 18. In someembodiments, when the needle 4 is pushed into and through the skive 18along the tip 38, the needle 4 pushes against the core wire 42 and/orribbon 44 such that the material of the tip 38 is stretched or fitsclosely over the needle 4 and core wire 42 and/or ribbon 44 to create asecure engagement between the needle 4 and guidewire 16 as discussedherein.

The ribbon 44 can taper in size or continue to gradually and/or smoothlytaper in size from the skive 18 along a length of the needle 4 (e.g.,along a direction to the distal end 6 of the needle 4). As illustratedin FIG. 5, the ribbon 44 can run or extend adjacent to the needle 4,proceeding distally to the skive 18. The ribbon 44 can terminateproximate to a midpoint of the needle 4. In some embodiments, the ribbon44 may terminate proximate to the skive 18. In some embodiments, theribbon 44 may terminate proximate to the distal section 40 of the tip38. The ribbon 44 can terminate anywhere along a length of theengagement of the tip 38 over the needle 4.

As illustrated in FIG. 5, the core wire 42 can be substantially roundwith a diameter corresponding to the inner diameter of the tip 38. Asthe core wire 42 tapers and/or transitions to the ribbon 44 as discussedherein, the profile of the core wire 42 can reduce and/or flatten to aprofile as illustrated in FIG. 6 (e.g., rectangular).

FIG. 6 is a cross-sectional profile view of an embodiment of a tip 38, aneedle 4, and a ribbon 44. As illustrated in FIG. 6, the tip 38surrounds, contains, houses, and/or envelops the needle 4 and the ribbon44. The inner diameter of the tip 38 corresponds to the outer diameterof the needle 4 and the ribbon 44 such that the ribbon 44 rests againstor is pressed against the corresponding surfaces of the tip 38 and theneedle 4. In some embodiments, the ribbon 44 can be imbedded into thematerial of the tip 38. As illustrated in FIG. 6, the tip 38 can have apredetermined internal diameter that can accommodate both the needle 4and the ribbon 44 without or substantially sacrificing the structuralintegrity of the tip 38 (e.g., tearing the polymer of the tip 38). Asillustrated in FIGS. 5 and 6, the tapering core wire 42 and/or ribbon 44can run opposite to the skive 18 and/or along the needle 4 forreinforcement of the adjacent/mating components and to allow forpushability forces to be transferred adequately when the user pushes theguidewire 16 over the needle 4 and into the body tissue (e.g.,vasculature)

As discussed herein, a balance may be achieved between a stiffnessand/or rigidity of the guidewire 16 and the guidewire angle 22 impartedon the guidewire 16 by the luer 10 for a desired pushability or abilityof the vascular access system 2 to push the guidewire 16 through andinto the living tissue (e.g., vasculature). Further, the extension ofthe core wire 42 through the guidewire 16 and tapering into the ribbon44 to run adjacent the needle 4 as discussed herein can achieve desiredpushability of the guidewire 16 by, for example, the guidewire 42 (andribbon 44) transferring the pushability forces along the needle 4 (e.g.,shaft of the needle 4) to allow the guidewire 16 to pass through thebody tissue (e.g., skin) into, for example, the vasculature. Stateddifferently, the core wire 42 and the ribbon 44 provide for thepushability of the guidewire 16 (e.g., ability to push through and enterbody tissue when a user pushes on the guidewire 16, such as at the coil52).

FIG. 7 illustrates a side view of an example embodiment of a needle 4and a guidewire 16 over the needle 4. The guidewire 16 is showntransparently for illustration purposes. In particular, the tip 38 ofthe guidewire 16 is shown transparently to illustrate other componentsof the guidewire 16 as discussed herein. The guidewire 16 can have askive 18 as discussed herein that can be in communication with or opento a lumen of the guidewire, and in particular, in communication with oropen to a lumen formed by a tip 38. As discussed herein, the core wire42 in the tip 38 can correspond substantially to an inner diameter ofthe tip 38 at certain portions of the guidewire 16. As the core wire 42approaches the skive 18, the core wire 42 tapers to at least partiallyocclude the opening of the skive 18. The core wire 42 tapers into theribbon 44 that can extend adjacent the needle 4 in the tip 38 such thatpushability forces on guidewire 16 are communicated through the corewire 42 along the needle 4 as discussed herein.

The skive 18 can have a skive opening 46 with a dimension X. In anembodiment, the skive opening 46 can be about 0.060″ in length Xcorresponding to, for example, the tip 38 has a 0.024″ ID and 0.035″ ODas discussed herein. In some embodiments, the skive opening 46 can havea length X of about 0.050, 0.051, 0.052, 0.053, 0.054, 0.055, 0.056,0.057, 0.058, 0.059, 0.060, 0.061, 0.062, 0.063, 0.064, 0.065, 0.066,0.067, 0.068, 0.069, and 0.070″, including the foregoing values andranges bordering therein, between about 0.030″ and about 0.100″, betweenabout 0.050″ and about 0.070″, or between about 0.055″ and about 0.065″for example.

The skive 18 can have a skive length 48 with a dimension Y. In anembodiment, the skive length 48 can be about 0.080″ in length Y when,for example, the tip 38 has a 0.024″ ID and 0.035″ OD as discussedherein. In some embodiments, the skive opening 46 can have a length Y ofabout 0.070, 0.071, 0.072, 0.073. 0.074, 0.075, 0.076, 0.077, 0.078,0.079, 0.080, 0.081, 0.082, 0.083, 0.084, 0.085, 0.086, 0.087, 0.088,0.089, and 0.090″, including the foregoing values and ranges borderingtherein, between about 0.050″ and about 0.100″, between about 0.070″ andabout 0.090″, or between about 0.075″ and about 0.085″ for example.

The skive 18, skive opening 46, and/or skive length 48 can be sized andshaped to achieve a predetermined skive support 50. The skive support 50can be a minimum material length Z of the tip 38 material that isretained in the tip 38 after the skive 18 is fabricated (e.g., cut outof the tip 38, or any other suitable manufacturing method). Asillustrated in FIG. 7, the skive support 50 can be a minimum length Z ofmaterial between a point on the skive 18 and the tip 38. In someembodiments, the skive support 50 length Z is a minimum predeterminedlength relative to the diameter of the tip 38. For example, the skivesupport 50 length Z can be a minimum length such that a perimeter orperiphery of the skive 18 is above or does not cross a central axis ofthe tip 38 and/or guidewire 16 relative to the view illustrated sideview of FIG. 7 (e.g., a plane along a central axis of the tip 38extending perpendicularly from the view of FIG. 7). In such embodiments,a minimum amount of material of the tip 38 is present about or proximateto the skive 18 to support and retain the core wire 42, ribbon 44,and/or needle 4 in desired position and facilitate the transferpushability of forces as discussed herein.

In an embodiment, skive support 50 can be about 0.025″ in length Z when,for example, the tip 38 has a 0.024″ ID and 0.035″ OD as discussedherein. In some embodiments, the skive opening 46 can have a length Z ofabout 0.015, 0.016, 0.017, 0.018. 0.019, 0.020, 0.021, 0.022, 0.023,0.024, 0.025, 0.026, 0.027, 0.028, 0.029, 0.030, 0.031, 0.032, 0.033,0.034, and 0.035″, including the foregoing values and ranges borderingtherein, between about 0.010″ and about 0.050″, between about 0.015″ andabout 0.035″, or between about 0.020″ and about 0.030″ for example, orany other suitable length to be greater than the central axis of the tip38 as discussed herein.

FIG. 8 illustrates a side view of an embodiment of a guidewire 16. Asdiscussed herein, the guidewire 16 can have a tip 38 with a skive 18. Aneedle 4 can enter the tip 38 via the skive 18. The guidewire 16 canhave a coil 52 that connects to the tip 38 to form the guidewire 16.

FIG. 9A illustrates an enlarged side view of an embodiment of aguidewire 16. FIG. 9B illustrates an enlarged side of a cross-section ofan embodiment of a guidewire 16. As illustrated in FIG. 9B, the coil 52can be formed from coiled or winding material (e.g., wire, cord, cable,etc.) to form an inner diameter. The core wire 42 can continue throughthe coil 52 within the inner diameter of the coil 52 through the rest ofthe length of the guidewire 16 (e.g., proximal section of the guidewire16 as discussed herein). The core wire 42 can be concentric to the coil52. In some embodiments, the coil 52 of the guidewire 16 may be formedfrom a solid wire material without a central lumen for the core wire 42.For example, the core wire 42 may terminate at and/or be connected tothe coil 52 (e.g., solid body wire). In some embodiments, the core wire42 diameter may expand into the outer diameter of the guidewire 16 wherethe tip 38 terminates to form the third proximal section of theguidewire 16 as discussed herein.

The coiled or winding material of the coil 52 can be stainless steel,nitinol (nickel titanium), and/or other suitable metals or metal alloys.In some embodiments, the coil 52 can be made from or in addition withpolymers as discussed herein, for example, in reference to the materialsof the tip 38.

The coiled material of the coil 52 can be formed from, for example, awire/cord/cable that has a diameter of 0.006″ inches. In someembodiments, the diameter of the coiled or winding material that formsthe coil 52 can be about 0.001, 0.002, 0.003, 0.004, 0.005, 0.006,0.007, 0.008, 0.009, 0.010, 0.011, and 0.012″, including the foregoingvalues and ranges bordering, including the foregoing values and rangesbordering therein, or any other suitable diameter to form the coil 52 asdiscussed herein, such as between about 0.001″ and about 0.020″, betweenabout 0.002″ and about 0.010″, or between about 0.002″ and about 0.008″for example. As illustrated in FIGS. 9A and 9B, the inner and outdiameters of the coil 52 as formed by the coiled material can correspondto the inner and outer diameters of the tip 38. The inner and outerdiameters can be diameters as discussed herein in reference to the tip38 and/or guidewire 16. For example, in one embodiment, the outerdiameter of the coil 52 is about 0.035″ and the inner diameter is about0.024″.

Returning to FIG. 8, a section of the guidewire 16 having the coil 52can be considered a first or proximal (relative to a user) section ofthe guidewire 16. As discussed herein, the first proximal section of theguidewire 16 can include the core wire 42 and the coil 52. A section ofthe guidewire 16 having the skive 18 can be considered a second ormiddle (relative to a user) section of the guidewire 16. As discussedherein, the second middle section of the guidewire 16 can include thetip 38, the core wire 42, the ribbon 44, and/or the skive 18. A sectionof the guidewire 16 with the tip 38 over or configured to be over theneedle 4 can be considered a third or distal (relative to a user)section of the guidewire 16. As discussed herein, the third distalsection can include the tip 38, the core wire 42, and/or the ribbon 44.Particular sections of the guidewire 16 may vary and the components thatthe particular sections include as part of the guidewire 16 may vary.Sections of the guidewire 16 as discussed herein are for discussionpurposes and not limiting.

In some embodiments, the guidewire 16 can be about 18″ in overall orentire length (e.g., the length of the combined lengths of the first,second, and third sections of the guidewire 16 as discussed herein). Insome embodiments, the guidewire 16 can be about 12, 13, 14, 15, 16, 17,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30″ in length, includingthe foregoing values and ranges bordering there, or any other suitablelength of guidewire 16 to enter the body tissue and reach a desiredlocation (e.g., lumen) or insertion length of the guidewire 16 into thebody tissue, between about 6″ and about 36″, between about 12″ and about30″, or between about 18″ and about 26″ for example. In someembodiments, the first proximal section of the guidewire 16 can have alength that is less than about 90, 85, 80, 75, 70, 65, 60, 55, 50, 45,40, 35, 30%, or less with respect to the entire length of the guidewire16, or between about 50-90%, about 60-85%, or about 60-80% of the entirelength of the guidewire 16). In some embodiments, the first and secondsections of the guidewire 16 can have a length that is less than about70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 15, 10%, or less withrespect to the entire length of the guidewire 16, or between about20-60%, about 25-50%, or about 25-40% of the entire length of theguidewire 16. The second section of the guidewire 16 can be a lengthsuch that upon insertion of the tip 38 onto the needle 4, the secondsection (e.g., the tip 38) extends through an entire length of theguidewire lumen 20. In some embodiments, the guidewire 16 may not havesections as discussed herein and can have a solid core (no centrallumen, and thus the first and second sections of the guidewire may notbe an over-the-needle assembly).

FIGS. 10A-D illustrate an example method of using the vascular accesssystem 2 as discussed herein. FIGS. 10A-D illustrate accessing a bodylumen 54, such as a blood vessel (e.g., body tissue as discussedherein), with the vascular access system 2. FIG. 10A illustratespuncturing the body lumen 54 with the vascular access system 2 (e.g., aneedle loaded with an over-the-needle wire as discussed herein). Stateddifferently, the vascular access system 2, and particularly, the needle4 and guide 16 are advanced into the body lumen 54. Upon accessing thebody lumen 54, a user may see a backbleed or flash of blood in the luer10 indicating access of the body lumen 54. In some embodiments, theprocedure involves minimal or no blood dripping onto the operativefield. Next (step not shown), the guidewire 16 can then be advanced intothe body lumen 54 while substantially maintaining the position of theneedle 4 relative to the body lumen 54. FIG. 10B illustrates withdrawingthe needle 4 while maintaining the guidewire 16 in position relative tothe body lumen 54. FIG. 10C illustrates inserting or advancing a sheath56 and dilator 58 into the body lumen 54 over the guidewire 16. Thesheath 56 and dilator 58 can have inner diameters greater than that ofthe outer diameter of the guidewire 16. After inserting the sheath 56and dilator 58, the guidewire 16 and dilator 56 can be withdrawn,leaving the sheath 56 inside the body lumen 54. In some embodiments,puncturing the body lumen 54 can be via a percutaneous or cut-downapproach. In some embodiments, the method could include, e.g., needle,wire, sheath, and dilator features as discussed herein. Followingsuccessful access into the body lumen, e.g., the artery or vein, variousadditional diagnostic and therapeutic procedures can be readilyperformed. For example, arterial or venous blood can be collected fordiagnostic sampling. In some embodiments, the access can be used forrapid infusion of, for example, intravenous fluids such as saline, oneor more therapeutic agents, or blood or a component product, forexample. In some embodiments, a catheter can be inserted into the accessport for performance of a procedure, such as angiography for example,Swan-Ganz catheterization, or delivery of a medical device such as astent or heart valve, for example. In some embodiments, once access isobtained, the vascular access system or components thereof can beexchanged over-the-wire for a larger gauge catheter system, such as aQuinton or Mahurkar catheter for dialysis access for example.

The dilator-sheath assembly 56, 58 as discussed herein and in referenceto FIG. 10D can include an introducer sheath 56 (e.g., a 12 Frenchsheath), and a dilator 58 that can be about 0.035″ OD compatible, forexample. The introducer sheath 56 can have a central lumen sized andconfigured to house the over-the-needle guidewire 16 therethrough.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a catheter into the internal jugular vein”includes “instructing the insertion of a catheter into the internaljugular vein.” It is to be understood that such depicted architecturesare merely examples, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermediary components. The ranges disclosed hereinalso encompass any and all overlap, sub-ranges, and combinationsthereof. Language such as “up to,” “at least,” “greater than,” “lessthan,” “between,” and the like includes the number recited. Numberspreceded by a term such as “approximately”, “about”, and “substantially”as used herein include the recited numbers, and also represent an amountclose to the stated amount that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan 10% of, within less than 5% of, within less than 1% of, within lessthan 0.1% of, and within less than 0.01% of the stated amount.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced embodiment recitation is intended, suchan intent will be explicitly recited in the embodiment, and in theabsence of such recitation no such intent is present. For example, as anaid to understanding, the disclosure may contain usage of theintroductory phrases “at least one” and “one or more” to introduceembodiment recitations. However, the use of such phrases should not beconstrued to imply that the introduction of an embodiment recitation bythe indefinite articles “a” or “an” limits any particular embodimentcontaining such introduced embodiment recitation to embodimentscontaining only one such recitation, even when the same embodimentincludes the introductory phrases “one or more” or “at least one” andindefinite articles such as “a” or “an” (e.g., “a” and/or “an” shouldtypically be interpreted to mean “at least one” or “one or more”); thesame holds true for the use of definite articles used to introduceembodiment recitations. In addition, even if a specific number of anintroduced embodiment recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). In those instances where a conventionanalogous to “at least one of A, B, or C, etc.” is used, in general sucha construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, embodiments, or drawings, should be understood tocontemplate the possibilities of including one of the terms, either ofthe terms, or both terms. For example, the phrase “A or B” will beunderstood to include the possibilities of “A” or “B” or “A and B.”

Although the present subject matter has been described herein in termsof certain embodiments, and certain exemplary methods, it is to beunderstood that the scope of the subject matter is not to be limitedthereby. Instead, the Applicant intends that variations on the methodsand materials disclosed herein which are apparent to those of skill inthe art will fall within the scope of the disclosed subject matter.

What is claimed is:
 1. A vascular access system comprising: a needlehaving a proximal end, a sharpened distal end, a tubular body, and acentral lumen therethrough; an over-the-needle guidewire configured tofit over the outside diameter of the needle, the guidewire comprising aproximal section and a distal section, wherein the proximal sectioncomprises a first cross-sectional profile in the proximal section,wherein the distal section comprises an outer tubular sidewall, a skivein the outer tubular sidewall configured for passage of the needletherethrough, the guidewire having the first cross-sectional profileproximally and a second cross-sectional profile distally, and atransition zone between the first cross-sectional profile and the secondcross-sectional profile, wherein the second cross-sectional profile issmaller than the first cross-sectional profile; and a luer connectoroperably connected to the needle having at least one input port fluidlyconnected to the central lumen of the needle, and a guidewire lumen notfluidly connected to the central lumen of the needle, the guidewirelumen configured to slidably house the guidewire therethrough, theguidewire lumen having a longitudinal axis that forms an acute anglewith respect to a longitudinal axis of the luer connector.
 2. A vascularaccess system comprising: a needle having a proximal end, a sharpeneddistal end, a tubular body, and a central lumen therethrough; anover-the-needle guidewire configured to fit over the outside diameter ofthe needle, the guidewire comprising a first proximal section, a secondmiddle section, and a third distal section, wherein the first proximalsection comprises a first cross-sectional profile in the first proximalsection, wherein the second middle section comprises an outer tubularsidewall, a skive in the outer tubular sidewall configured for passageof the needle therethrough, the guidewire having the firstcross-sectional profile proximally and a second cross-sectional profiledistally, and a transition zone between the first cross-sectionalprofile and the second cross-sectional profile, wherein the secondcross-sectional profile is smaller than the first cross-sectionalprofile, and wherein the third distal section comprises the outertubular sidewall having the second cross-sectional profile; and a luerconnector operably connected to the needle having at least one inputport fluidly connected to the central lumen of the needle, and aguidewire lumen not fluidly connected to the central lumen of theneedle, the guidewire lumen configured to slidably house the guidewiretherethrough, the guidewire lumen having a longitudinal axis that formsan acute angle with respect to a longitudinal axis of the luerconnector.
 3. The system of claim 2, wherein the first proximal sectionfurther comprises a coil disposed at least partially over a core wire.4. They system of claim 3, wherein the core wire at least partiallyoccludes the skive.
 5. The system of claim 3, wherein the coil of thefirst proximal section comprises a wire circumferentially wound about acentral coil axis to form the coil, wherein the wire has an outerdiameter of 0.006 inches, and wherein the coil formed from the woundwire has an outer diameter of about 0.035 inches.
 6. The system of claim2, wherein the longitudinal axis of the luer connector is parallel to alongitudinal axis of the needle, wherein when the guidewire slidesthrough the guidewire lumen, the guidewire in the guidewire lumen ispositioned at the acute angle relative to the longitudinal axis of theneedle.
 7. The system of claim 6, wherein the acute angle of theguidewire is formed at the skive in the second middle section of theguidewire.
 8. The system of claim 2, wherein the acute angle is betweenabout 5 to 45 degrees.
 9. The system of claim 8, wherein the acute angleis about 15 degrees.
 10. The system of claim 2, wherein the outertubular wall of the second middle section and the third distal sectionextends from the skive through the guidewire lumen when the guidewire ispositioned over the needle.
 11. The system of claim 2, wherein theguidewire covers a majority of an overall length of the needle when theguidewire is positioned over the needle.
 12. The system of claim 2,wherein an outer diameter of the needle is about 0.022 inches and aninner diameter of the guidewire at the third distal section is about0.024 inches.
 13. The system of claim 12, wherein the inner diameter ofabout 0.024 inches extends through second middle section and the firstproximal section.
 14. The system of claim 2, wherein the guidewire hasan entire length of about 45 centimeters.
 15. A vascular access systemcomprising: a needle having a proximal end, a sharpened distal end, atubular body, and a central lumen therethrough; an over-the-needleguidewire configured to fit over the outside diameter of the needle, theguidewire comprising a first proximal section, a second middle section,and a third distal section, wherein the first proximal section comprisesa core wire and a coil disposed over the core wire, the core wire havinga first cross-sectional profile in the first proximal section, whereinthe second middle section comprises an outer tubular sidewall, a skivein the outer tubular sidewall configured for passage of the needletherethrough, and the core wire disposed within the outer tubularsidewall, the core wire having the first cross-sectional profileproximally and a second cross-sectional profile distally, and atransition zone between the first cross-sectional profile and the secondcross-sectional profile, wherein the second cross-sectional profile issmaller than the first cross-sectional profile, and wherein the thirddistal section comprises the outer tubular sidewall, and the core wirehaving the second cross-sectional profile, the core wire extending atleast partially through the outer tubular sidewall in the third section;and a luer connector operably connected to the needle having at leastone input port fluidly connected to the central lumen of the needle, anda guidewire lumen not fluidly connected to the central lumen of theneedle, the guidewire lumen configured to slidably house the guidewiretherethrough, the guidewire lumen having a longitudinal axis that formsan acute angle with respect to a longitudinal axis of the luerconnector.
 16. The system of claim 15, wherein the longitudinal axis ofthe luer connector is parallel to the a longitudinal axis of the needle,wherein when the guidewire slides through the guidewire lumen, theguidewire in the guidewire lumen is positioned at the acute anglerelative to the longitudinal axis of the needle.
 17. The system of claim16, wherein the acute angle of the guidewire is formed at the skive inthe second middle section of the guidewire.
 18. The system of claim 15,wherein an outer diameter of the guidewire tapers substantially to anouter diameter of the needle at the third distal section proximate tothe sharpened distal end of the needle.
 19. The system of claim 15,wherein a cross-sectional profile of the transition zone of the corewire between the first cross-sectional profile and the secondcross-sectional profile is about 0.010 inches in a dimension of thecross-sectional profile of the transition zone.
 20. The system of claim15, wherein a combined length of the second middle section and the thirddistal section is less than about 30% of an entire length of theguidewire.